Ducci and Teixeira Want Ministry of Health to Clarify Secret Agreement with Company for Supply of Cannabidiol in the SUS
The deputies want the government to answer six questions, one of them regarding the incorporation in the SUS of a specific product linked to only one manufacturer and not related to the active ingredient
Charles Vilela
Federal deputies Paulo Teixeira (PT-SP) and Luciano Ducci (PSB-PR) formalized a request to the Ministry of Health, through a petition, for the department to provide information on the "Technical Cooperation Agreement for Technology Transfer for the production of the product Cannabidiol, among other agreements" signed between the Oswaldo Cruz Foundation and the company Prati, Donaduzzi & Cia Ltda.
Teixeira is the president of the Special Commission on Medicines Formulated with Cannabis of the Chamber of Deputies, while Ducci is the rapporteur of the substitute for bill 399/2015 that will regulate the cultivation, processing, research, production, and commercialization of Cannabis-based products for medicinal and industrial purposes.
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On October 23, the Ministry of Health celebrated an agreement for the transfer of technology and supply of the product Cannabidiol 200mg/ml, which is exclusively produced by the company Prati, Donaduzzi & Cia Ltda. The agreement, which is confidential, provides for the supply of the medicine or product based on medicinal marijuana. The Oswaldo Cruz Foundation, through the Institute of Technology in Drugs (Farmanguinhos), will be responsible for the operationalization of the contract.
The deputies want the Ministry of Health to answer six questions (see all at the end of the article), including why the "Oswaldo Cruz Foundation expressed interest in mastering the technique of producing cannabinoid medicines, why restrict solely to the use of cannabidiol, considering the wide range of therapeutic uses of cannabinoids that often require the concomitant administration, in the same formulation, of tetrahydrocannabinol, as is the case with the first cannabinoid medicine registered by the National Health Surveillance Agency – ANVISA?"
Another question from the parliamentarians is about the incorporation in the SUS of a specific product linked to only one manufacturer and not related to the active ingredient, which is cannabidiol that can be used in various concentrations. "Considering that cannabidiol is an active ingredient that varies in concentration depending on the patient's therapeutic needs, and that there are other Cannabis Products in the process of obtaining sanitary authorization from the National Health Surveillance Agency – ANVISA, why was the decision made to include the said active ingredient linked to a specific concentration of a particular brand?", the deputies inquire.
See the questions sent by the parliamentarians to the Ministry of Health:
"1) What is the object, or objects, and the terms of the agreement, which vaguely refers to “other agreements”?
2) If the Oswaldo Cruz Foundation expressed interest in mastering the technique of producing cannabinoid medicines, why restrict solely to the use of cannabidiol, considering the wide range of therapeutic uses of cannabinoids that often require the concomitant administration, in the same formulation, of tetrahydrocannabinol, as is the case with the first cannabinoid medicine registered by the National Health Surveillance Agency – ANVISA?
3) Are there plans, as a result of the agreement, to promote the free distribution of medicines with cannabidiol by the Unified Health System – SUS? In this case, does the Ministry have estimates of the demand to be met and the timeframe for the start of distribution?
4) Considering that the cultivation of the Cannabis sativa plant is still prohibited by national legislation, what would be the source of the raw material to be used in the large-scale production of cannabinoid medicines?
5) Considering that Cannabidiol is an active ingredient that varies in concentration depending on the patient's therapeutic needs, and that there are other Cannabis Products in the process of obtaining sanitary authorization from the National Health Surveillance Agency – ANVISA, why was the decision made to include the said active ingredient linked to a specific concentration of a particular brand?
6) Will the Ministry of Health acquire the aforementioned product from the company Prati, Donaduzzi & Cia Ltda.? If so, what is the estimated public resource investment in this acquisition?"